Draft Guidance for Industry on Topical Dermatological Drug Product NDAs and ANDAs-In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Withdrawal

Resumo

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled "Topical Dermatological Drug Product NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies." After careful consideration of the comments from the public and public advisory committees, FDA has decided to withdraw the draft guidance.